International cooperation on therapeutic products

Swissmedic authorises a new active substance (NAS) under the ACSS Consortium initiative for the first time


For the first time Swissmedic, the Swiss Agency for Therapeutic Products, has authorised a new active substance (NAS) under the ACSS Consortium NAS Work Sharing Initiative with the partner authorities Health Canada (HC) and the Australian Therapeutic Goods Agency (TGA). Based on this new form of cooperation between drug regulatory authorities, the three agencies authorised baloxavir marboxil (Xofluza®) for the treatment of uncomplicated influenza in patients 12 years of age and older.

Xofluza is therefore the fourth authorisation to be issued in connection with the NAS Work Sharing Initiative (NASWSI), but the first in which Switzerland was also involved. For the first time, Swissmedic was thus able to actively participate in the initiative and contribute to the international work sharing project. Health Canada and TGA had already authorised three new active substances under the NASWSI.

The ACSS Consortium is a collaborative initiative of like-minded, medium-sized regulatory authorities. Apart from Swissmedic, the other members are TGA, Health Canada (HC) and the Health Sciences Authority (HSA) of Singapore. The individual regulatory authorities are faced with very similar challenges, particularly growing workloads and increasingly complex scenarios for regulated therapeutic products. The purpose of the consortium is to exploit synergies, share knowledge among the regulatory authorities and thereby enhance the efficiency of the regulatory systems and optimise the demand for resources.

The ACSS Consortium consists of several working groups with various objectives and projects that aim to help meet the challenges faced by regulatory authorities including, in particular, the timely access to safe therapeutic products despite limited resources. The working groups use a network of bilateral Confidentiality Agreements and Memoranda of Understanding as a basis for their work.

For the assessment of the application, the main review of modules 3 (Quality), 4 (Preclinical) and 5 (Clinical) was divided up amongst the three authorities (M3: Health Canada; M4: Swissmedic; M5: TGA). Each agency independently reviewed its own country-specific Module 1 and the Risk Management Plan. A consolidated List of Questions was sent to the marketing authorisation holder, and timelines were synchronised up until the national labelling phase. At the end, each authority made its own independent decision on the marketing authorisation of the medicinal product. In the case of baloxavir marboxil, the authorisation was issued by all three regulatory authorities after a review period of just 265 days.

The NAS Work Sharing Initiative (NASWSI) currently offers a standard and fast-track procedure for new active substances, as well as a procedure for adding indications. Further information on the initiative and medicinal products authorised via NASWSI can be found under the following links: